Principal Scientist (m/w/d)

via temporary employment

Our client is a global player in the pharmaceutical industry. As a researching and tradition company, our customer is present worldwide. With more than thousand employees, the German location also takes on an important role.

 

At the earliest possible date we are looking for a

Principal Scientist (m/w/d)

via temporary employment

  • Bereich:

    Medical

  • Berufssparte:

    Forschung/Entwicklung

  • Arbeitsregion:

    Großraum Konstanz

  • Art der Anstellung:

    Interim

  • Kennziffer:

    25927

  • Aktualisierung:

    28.04.2020

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Your tasks

  • Responsible for technical management of commercial production for a defined portfolio of pharmaceutical products and CMOs
  • Maintain technical product expertise and ensure GMP and regulatory compliance at CMOs
  • Collaborative resolution of technical issues encountered at CMOs to support product supply
  • Execution of IQ/OQ/PQ/MQ protocols, site level tech transfer, and continuous improvement activities at CMOs
  • Support of day-to-day manufacturing operations at CMOs and resolution of issues (e.g. deviations, investigations)
  • Technical visits at CMOs and participation in audits and inspections
  • Technical transfers and GMP qualification/validation activities incl. approval of documents
  • Cooperation with Regulatory Affairs regarding Change Control, Notifications, Renewals of Registrations
  • Writing and compilation of CMC documents including processing of the CMC Module 3 Document Sections for products in scope
  • Legalization of GMP- and Manufacturing Authorizations
  • Cooperation with Quality group regarding QA issues (e.g. complaints, deviations, OOS/OOT)
  • Support process optimization and improvement activities within department and towards the CMOs
  • Ensure launch of existing products in new markets and participate in launch of new in-licensed products
  • Support interdisciplinary working/reporting and interdepartmental cooperation
  • Technical input for quality and supply agreements, CDAs and Start-up agreements
  • Applied Risk Management, Project and Alliance Management
  • Product binder compilation and maintenance
  • Coordination of stability studies

Your qualification

  • Degree in Pharmacy, Chemistry, Biology, Process Engineering or equivalent
  • Minimum five years of experience in project management, production, QA and/or QC within the pharmaceutical industry
  • Good knowledge of regulatory requirements regarding manufacture of medicinal products.
  • Knowledge of relevant manufacturing processes and technologies
  • General understanding of pharmaceutical business (incl. technical pharmaceutical knowledge, regulatory, legal and commercial aspects)
  • Experience/knowledge about GMP regulations and requirements
  • Experience in collaboration with contract manufacturing organizations
  • Ability to solve complex situations and problems in a results-oriented manner
  • Good collaboration and communication skills and be a team player
  • Fluency in verbal and written English
  • Conversational skills in german language

Benefits

  • A fast and professional introduction and personal support from the beginning of the application process
  • Working in a modern working environment
  • Work-life balance
  • Flexible working times
  • Fair pay and attractive industry bonuses
  • Awards, holiday and Christmas bonuses
  • Further training and education opportunities
  • Diverse services and discounts with well-known cooperation partners
  • With us a constantly available contact person

 

Ihre Ansprechpartnerin

Bettina Cöppicus
Senior Personalberaterin

Anschrift

Optares ICM GmbH & Co. KG
Bettina Cöppicus
Heiligengeist Höfe 8
26121 Oldenburg